The number of drug shortages in the United States has tripled since 2005, hitting treatments for rare cancers particularly hard. The shortages have federal officials “scrambling” to find a remedy, the New York Times reported over the weekend. Solutions could range from a national drug stockpile to an overhaul of how we price rare drugs. Rep. Diana DeGette (D-Colo.) has been a congressional leader on the issue, introducing a bill in June that would require drug companies to notify the FDA of impending shortages. The bill, introduced with Rep. Tom Rooney (R-Fla.), is a companion to a Senate proposal from Sen. Amy Klobuchar (D-Minn.)
I reached Rep. DeGette in this afternoon in Denver, part of her home district, to discuss why drug shortages have spiked and what Congress can - and can’t - do about it. What follows is a lightly edited transcript of our conversation.
Sarah Kliff: I was hoping you could start by walking me through the problem we’re facing with drug shortages right now and what can be done about it.
Rep. Diana DeGette: It’s a problem that’s crept up on us. All of a sudden we started hearing from hospitals and physicians that they were having drug shortages with a wide range of drugs, but in particular, drugs that are used to treat a narrow niche of childhood cancers. These providers weren’t finding out about the drug shortage until middle of treatment protocol, when suddenly they couldn’t get it anymore.
S.K.: FDA statistics show that the number of drug shortages has tripled recently. Do we know why that’s happening?
D.D.: It’s one of those situations where there seem to be a variety of factors [and] difficult to pinpoint what has caused drug shortages...I’ve read some of the different articles with drug companies. Some [explanations] sound like they might be reasonable but others sound like excuses.
S.K.: What sounds like an excuse to you?
D.D.: I can’t really say globally. It’s hard to put a finger on it. They say “well, there’s an increased demand” but there can’t possibly be an increased demand for all drugs. It might increase for some but not others. Some say it’s a cost issue, but I haven’t seen the data to support that. I don’t think there’s one clear answer and I don’t even know if the drug companies could give you clear data at this point.
As we’ve gone forward with our legislation we have worked with pharmaceutical companies and have worked with [the biotech industry’s association]. We don’t want to be punitive. We want to help them identify when they might have a drug shortage and help the providers find alternatives.
S.K.: Your legislation would require drug companies to report impending shortages to the FDA. How would that help address the problem?
D.D.: Right now, we don’t have any kind of early warning system. What would happen [with the new legislation] would be pharmaceutical companies anticipating a shortage would have to notify the FDA, and the FDA would notify providers. The intent is to allow the providers to find an other source of the drug or undertake a different course of treatment.
S.K.: I understand how that helps providers, but would that that reduce the number of shortages?
D.D.: The hope is ultimately that having an early warning system will allow drug companies to better identify where they need to beef up production.
S.K.: Do you get a sense that this legislation has potential to move in this Congress?
D.D.: The good news is it’s bicameral and bipartisan. This is a piece of legislation that might have a good chance. I’ve already spoken with both Chairman [Cliff Stearns (R-Fla.), chair of the Energy and Commerce Committee’s Investigations and Oversight Subcommittee] and [Rep. Fred Upton, chairman of the Energy and Commerce Committee] about the potential of doing hearings. It hadn’t been particularly on Cliff’s radar but Congressman Rooney, who is my Republican cosponsor, had told him about how it was a terrible problem for Florida hospitals.
SK: What do you think about some of the non-legislative proposals out there? There’s been a decent amount of discussion of creating a national drug stockpile to combat shortages.
D.D.: Frankly, I’ve been focused on this. The problem with doing a national stockpile is there are so many types of drugs and they’re changing all the time. I think it might be worth looking into, especially for drugs that are difficult to manufacture. But it’s not like a petroleum reserve. There are so many thousands, maybe millions of drugs, and they’re continually changing.